Class I Defective Catheters Recalled by Medtronic

By Gilreath & Associates

Medtronic, a medical device company founded in 1949, recalled over 106,000 catheters in November 2019. It was categorized as a Class I recall, which is the most serious type of recall for medical devices, indicating that the product can potentially cause serious harm or even death to the consumers.

The United States Food and Drug Administration (FDA) issued the recall for Medtronic’s 6 French Sherpa NX Active Guide Catheters, and a specific subset of Euphora and Solarice Semi-Compliant Rapid Exchange Balloon Dilatation Catheters manufactured between February 27 and July 31, 2019.

Active guide catheters

These catheters are commonly used by doctors during coronary and peripheral interventional procedures to access veins and arteries inside and outside of the heart. Doctors can implement guidewires and other devices to administer medicine into the blood vessels. The danger is when catheters suddenly lose components into the bloodstream and expose the barbed wire.

Though no serious injuries were reported, at least 5 customers complained of their catheters breaking, which could be potentially fatal.

Balloon dilation catheters

Doctors using these types of catheters reported difficulty removing them from patients, which has been attributed to a slightly wider than normal diameter stylet. Any added pressure applied to the catheters in order to remove them could result in inflation or deflation of the balloon and cause prolonged procedure time, additional intervention and vessel injury.

Defective medical devices in Tennessee

Medtronic notified doctors of the defect immediately and worked with the FDA to remove the catheters from the healthcare system. But for patients who already had the medical devices implemented, it could cause potential harm.

If you or a loved one are suffering from a defective medical product, such as a catheter or other medical device, it’s best to get in touch with your doctor immediately. Then, seek legal counsel as soon as possible so you can receive the financial compensation you deserve.

In the state of Tennessee, according to the statute of limitations, consumers generally have only 1 year from the date of injury (or 1 year from the date the injury should’ve become known) to file a product liability claim. In addition, you can’t file a lawsuit if it has been more than 10 years from the product’s date of sale or within 1 year after its expiration, whichever comes first.

Filing a medical device defect claim

To file an injury claim in Tennessee, you should contact a lawyer with professional experience in defective medical products as soon as possible. Make sure you also secure the product, along with any documentation and proof of purchase. Do NOT give the product to the manufacturer, as this could reduce your chance of receiving fair compensation.

With 35 years of experience in over 12 different states, the lawyers at Gilreath & Associates have successfully represented clients in product liability cases with expert legal advice and a commitment to ensuring the best possible outcome.

Contact our Knoxville, Nashville or Memphis office today for your free consultation.

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